Weightbearing Restrictions on Postoperative Outcomes Following Arthroscopic Surgery for FAI

April 1, 2024 updated by: Panam Clinic

The Impact of Varying Weightbearing Restrictions on Postoperative Outcomes Following Arthroscopic Surgery for Femoroacetabular Impingement: a Randomized Trial

The purpose of this single-blinded (assessor) randomized trial is to compare patient-reported, clinical and functional outcomes in patients randomized to weight-bearing as tolerated (WBAT) or partial weight-bearing (PWB) restrictions following arthroscopic surgery for femoroacetabular impingement (FAI) up to 12-months postoperative.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this single-blinded (assessor) randomized trial is to compare patient-reported, clinical and functional outcomes in patients randomized to weight-bearing as tolerated (WBAT) or partial weight-bearing (PWB) restrictions following arthroscopic surgery for femoroacetabular impingement (FAI) up to 12-months postoperative. The primary objective is to compare the effects of WBAT or PWB restrictions on PROMS (International Hip Outcome Tool (iHOT33)) and clinical measures following arthroscopic intervention for FAI up to one-year post-operative. The secondary objective will be to assess differences in return to sport (RTS) PROMS, functional performance, and lower extremity kinetics, kinematics, and muscle activity during in patients randomized to either WBAT or PWB at six- and 12-months post-operative. The goal will be to answer if there are differences between a WBAT versus PWB rehabilitation protocol on patient-reported quality of life as measured by the International Hip Outcome Tool (iHOT33) at 12-m post-operative for patients undergoing primary hip arthroscopy for the treatment of FAI.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3M 3E4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 16 - 50 years of age at time of surgery

  • Diagnosis of FAI (cam, pincer, mixed) based on the 2016 Warwick Agreement. All 3 criteria below must be met:

    1. Symptoms of motion- or position-related pain in the hip or groin
    2. Clinical signs consistent with FAI such as: decreased hip flexion and internal rotation, or positive impingement sign
    3. Radiographic evidence (on BOTH x-ray AND non-contrast MRI) of intra-articular pathology consistent with FAI as determined by the treating surgeon.
  • Failed conservative interventions of at least 3 months (i.e. physiotherapy)
  • Have symptom relief with intra-articular injection of local anaesthetic
  • Unilateral or bilateral surgical intervention (note: unilateral required to ensure the weight bearing guidelines are followed)
  • Are willing to be followed for 12 months post-operative.

Eligibility for 'return to sport' cohort:

Additional assessment measures related to return to sport will be collected on the patient who meet the following criteria:

  • are or were previously actively involved in sport as indicated by a pre-operative Hip Sports Activity Scale score of four of greater
  • indicate a post-operative goal to return to sport following their procedure

Exclusion Criteria:

Clinical:

  • Previous surgery on the affected hip, or other major lower extremity orthopaedic surgery
  • Active joint or systemic infection, significant muscle paralysis, significant lower extremity or medical comorbidity that could alter the effectiveness of the surgical intervention (e.g. polymyalgia rheumatica)
  • Unable to speak or read English/French
  • Unable or unwilling to be followed for 1 year or complete functional testing
  • Presence of chronic pain syndromes
  • History of pediatric hip disease (i.e. Slipped Capital Femoral Epiphysis, Legg-Calve-Perthes Disease)
  • Ongoing litigation or compensation claims related to the hip (including Workers' Compensation)

Radiographic:

  • Osteoarthritis greater than Tönnis Grade 1 on affected hip
  • Lateral central edge angle <19°
  • Dysplasia in patients with broken Shenton line (i.e. Severe acetabular deformity present)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Partial Weight-bearing (PWB)
Patients will PWB for 3 weeks following surgery, followed by a gradual return to FWB.
Other: Partial Weight-bearing
The PWB group will be instructed to bear weight to a maximum of 20 lbs of bodyweight on the operative limb for the initial three weeks (termed "toe touch"), with graduated return to full weightbearing thereafter.
Experimental: Weight-bearing As Tolerated (WBAT)
Patients will WBAT immediately following surgery.
Other: Weight-bearing As Tolerated
The WBAT group will be instructed to bear weight as tolerated immediately following their surgical procedure. The rehabilitation protocols provided will be identical beyond the initial weightbearing recommendations. Following the initial protection phase (three weeks), whereby the two weightbearing interventions will be provided, patients will progress through standardized phases including mobility and neuromuscular retraining, muscle balance and strengthening, functional training, and finally, advanced training for return to work and sport.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
International Hip Outcome Tool (iHOT-33)
Time Frame: 12 months
The iHOT uses 33 questions to measure health-related quality of life. It is the primary outcome and has been validated for use in this population. Questions are evaluated on a 100-point visual analog scale (VAS) response format, where "0" represents the worst possible quality of life, and "100" represents the the best.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Non-contrast MRI
Time Frame: 0 months
Non-contrast MRI will be documented and used to assess for the presence of a labrum tear, articular cartilage lesions, cystic changes within the femoral neck or acetabulum.
0 months
Computed Tomography (CT) Scan
Time Frame: 0 months
All patients will undergo a pre-operative CT scan with three dimensional reconstructions of the hip joint. This permits improved visualization of the boney impingement lesions that are being treated at the time of surgery.
0 months
The Copenhagen Hip and Groin Outcome Score (HAGOS)
Time Frame: 12 months
HAGOS includes six separate subscales assessing pain, symptoms, physical function in daily living, physical function in sport and recreation, participation in physical activity and hip/groin-related quality of life and is designed for use with young to middle-aged physically active individuals with hip pain. Questions are answered on a five-point scale, with "0" indicating no problems, and 4 indicating extreme problems.
12 months
Hip Sports Activity Scale (HSAS)
Time Frame: 12 months
HSAS will indicate the patient's pre surgical and current level of sports participation using a nine-point scale ranging from no recreational or competitive sports ("0") to competitive, elite level sport ("8").
12 months
Hip Return to Sport after Injury scale (Hip-RSI)
Time Frame: 12 months
The Hip-RSI includes six questions regarding an athlete's readiness to return to sport using questions evaluating the athlete's emotional state, their confidence in performance, and their appraisal of risk related to their sport and injury. Each question is graded from 0 to 100, with variable definitions including 0 being "Not confident at all", and 100 being "fully confident", with higher scores indicating higher readiness to return to sport.
12 months
Single Assessment Numeric Evaluation (SANE) score
Time Frame: 12 months
The SANE score is a single question that asks patients to rate their affected hip as a percentage of normal to provide a simple and efficient measure of patient outcome 8. All patients will be asked the following question during their clinical exam: "How would you rate your affected hip today as a percentage of normal (0% to 100% scale with 100% being normal)?"
12 months
Rate of surgical complications, re-operations and revision surgeries
Time Frame: 12 months
Surgical complications will be documented at the time of surgery and at each postoperative interval. A surgical complication is defined as any undesirable, unintended and direct result of an operation affecting the patient that would not have occurred had the operation gone well as could reasonably be hoped (i.e. infection, neurological injury). Revisions and re-operations will be documented, including the reason for failure, date of revision/reoperation, and the procedure performed. A revision is defined as a subsequent surgery performed to correct or compensate for the initial procedure. Re-operation is defined as any surgical procedure other than a revision.
12 months
Postoperative Pain and Medication
Time Frame: 14 days
Postoperative pain will be self-reported on a 100mm visual analogue scale (VAS) in a logbook. Medication type and quantity will also be documented. The Postoperative Pain and Medication Logbook has been previously used by the authors in an ACL population. ) on the scale will represent "No pain at all", and 100 will represent "Wort pain possible".
14 days
Hip Isometric Muscle Strength
Time Frame: 12 months
Isometric hip abduction and extension will be measured in the side-lying and prone positions with a hand-held dynamometer (Chatillon DFX2, Ametek, PA, USA) positioned 5 cm proximal to the most prominent aspect of the malleolus. Four maximal holds of 5 seconds separated by 15 seconds rest will be completed after two submaximal familiarizations with 30 seconds of rest between attempts 25.
12 months
Hip Isokinetic Muscle Strength
Time Frame: 12 months
Five repetitions of concentric, isokinetic hip flexion and extension peak torque will be measured on an isokinetic dynamometer (Biodex, Medical System 3, NY, USA) with the patient in the supine position (0 degrees to 50 degrees hip flexion at 60 degrees/second). Hamstring strength will be measured with the NordBord Hamstring Dynamometer (Vald, Qld, Aus).
12 months
Jump Testing
Time Frame: 12 months
Participants will complete a standardized battery consisting of the drop vertical jump (jumping from a 30cm box to force plates positioned at a distance of 50% of their height from the starting line), a counter movement jump (jumping from the standing position with the hands on the hips on dual force plates), a squat jump and a single leg countermovement jump. Jump attempts will be recorded with three cameras (one frontal, two sagittal plane views) to assess maximal joint angles of the ankle, knee and hip. Anatomical markers for kinematic analysis of the lower extremity will be placed bilaterally at the following sites: anterior superior iliac spine, lateral iliac crest, greater trochanter, mid-thigh, medial and lateral knee joint line, tibial tubercle, mid-shank, distal shank, medial and lateral malleolus, and to the foot at the heel, dorsal surface of the lateral mid-foot, and toe with adhesive tape to the shoes
12 months
Hop Tests
Time Frame: 12 months
A standardized battery of hop tests will be completed including the single leg hop, triple hop, triple crossover hop and medial and lateral triple hops for distance. Distances will be measured from the starting line to the posterior surface of the heel at landing with a standard tape measure
12 months
5-0-5 Change of Direction (505)
Time Frame: 12 months
The participant will run 15 m, complete an 180o change of direction and run back to the starting line, with timing gates positioned at the 10 m mark to time the direction change (Brower Timing Systems, UT, USA).
12 months
Electromyography of the gluteal muscles
Time Frame: 12 months
Electromyographic (EMG) data will be collected per Surface Electromyography for the Non-Invasive Assessment of Muscles (SENIAM) standards on the upper and lower portions of the gluteus maximus muscle group (two finger widths above and below the midline between the posterior superior iliac spine and the greater trochanter of the femur for the upper and lower gluteus maximum respectively) and gluteus medius (proximal 1/3 of the distance between the iliac crest and the greater trochanter) following preparation of the skin (shaving and cleaning of the skin with isopropyl alcohol). Prior to testing, maximal voluntary isometric contractions of the gluteal muscles will be completed for normalization purposes. Peak EMG amplitudes for the gluteal muscles normalized to maximal voluntary isometric contractions will be collected during isometric hip abduction and extension and isokinetic hip flexion and extension and compared between the affected and unaffected limb, and between treatment groups
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Panam Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Devin Lemmex, MD, Pan Am Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Hip WB RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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